Finland Covid Vaccine NFCS

Introduction

Finland had an existing no-fault compensation scheme for vaccines created 1 May 1987, and which incorporated covid-19 vaccines from 21 December 2020.

This scheme is a non-statutory scheme, it consists of insurance for members of the Finnish Cooperative for Pharmaceutical Injury Indemnities. Membership of the Cooperative is voluntary. The vast majority of manufacturers, importers, marketers and sellers are members of the Finnish Co-Operative for Pharmaceutical Injury Indemnities. This means that the insurance covers nearly all medicines sold in Finland.

The Scheme ordinarily only covers medicines purchased in Finland. Section 3 of the Medicines Act (lääkelaki, 395/1987) states that all medicines that are sourced or obtained from Finland and intended for human use fall within the scope of pharmaceutical insurance if their manufacturer, importer, marketer or seller is a member of the Finnish Co-Operative for Pharmaceutical Injury Indemnities.

The Pharmaceutical insurance covers covid vaccines that have been procured in Finland via the EU common procurement mechanism. All of the covid vaccines either currently or previously administered in Finland were procured via the EU common procurement mechanism and so are covered by insurance.

The scheme is administered by the Finnish Mutual Insurance Company for Pharmaceutical Injury Indemnities, who are a captive owned by the Finnish Co-Operative for Pharmaceutical Injury Indemnities.

The funding for the scheme comes from insurance contributions levied on members of the Finnish Co-Operative for Pharmaceutical Injury Indemnities. For Covid vaccine claims there was a significant unknown and reinsurance was not available. Therefore, the Finnish Government granted an insurance guarantee to the Finnish Mutual Insurance Company for Pharmaceutical Injury Indemnities. A charge is levied for this guarantee in the same way as for reinsurance. The guarantee applies to coronavirus vaccines that are procured in Finland through the EU procurement mechanism.

Vaccines Covered

This NFCS covers EU approved vaccines, it therefore includes vaccines approved for emergency use and standard approvals. To be eligible under this NFCS the vaccine must have been:-

administered in Finland and
procured in Finland via the EU common procurement mechanism.

Injuries Covered

This NFCS covers both temporary and permanent injuries. To be eligible for compensation the vaccine recipient must have

suffered an incapacity to work or otherwise impaired bodily functions for not less than 30 consecutive days, or
sustained a permanent physical injury or illness, or
died.

Charges for making a claim

There is no charge for making a claim under this scheme.

Claimants

This is an insurance and the Insured is defined in the Terms and Conditions at point 3 as

‘The Insured shall denote the users of Pharmaceutical Products.’

Under this scheme the following categories of individuals are permitted to make a claim.

Vaccine recipient/their representative if the vaccine recipient is a child or incapacitated
A beneficiary of the estate of a deceased vaccine recipient
Survivor of a deceased vaccine recipient

Under this scheme the claimant is allowed to nominate another person, including a legal representative, to make their claim. Funding for legal representation is not provided by the scheme, but each health service has a patient ombudsman who can provide assistance with submitting the claim forms.

Losses covered

This scheme pays the following

Live Vaccine Recipient	Dependants of vaccine recipient	Estate of a deceased Vaccine Recipient
Both eligible economic and non-economic losses are compensated	Only eligible economic losses are compensated	Both eligible economic and non-economic losses are compensated

All payments in this scheme are secondary to other sources of compensation such as a social security payments and benefits. Quantification of claims is carried out according to the provisions of the Finnish Tort Liability Act (vahingonkorvauslaki, no. 412 of 1974) and any applicable norms and guidelines of the Traffic Accident Board. The following categories of payment are available.

Live Vaccine Recipients.

Costs incurred from pharmaceutical product damage. The includes necessary extraordinary medical expenses caused by the damage, such as hospitalisation and outpatient fees, medical fees, laboratory tests, the costs of medicines and physical therapy. Other eligible costs include travelling expenses incurred for extraordinary treatment.
Temporary incapacity. Compensation for temporary harm compensates the injured party for the pain, suffering and other temporary harm caused by the injury, seeking to make up for the associated loss of quality of life. The size of this compensation will depend on the nature and severity of the damage, the type and duration of treatment required, and the duration of the harm suffered. Compensation for temporary harm covers the time between the incidence of the personal injury until the state of health of the injured party has either been restored or has otherwise stabilised.
Permanent harm. Pharmaceutical insurance will pay compensation for any permanent functional disability caused by pharmaceutical product damage. This compensation is determined according to a decision of the Ministry of Social Affairs and Health (incapacity categories 1-20), and depends on such factors as the nature of the disability and the age of the injured party.
Permanent cosmetic harm. Compensation for cosmetic harm is payable for any permanent disfigurement, such as scarring due to pharmaceutical product damage. This compensation is determined in accordance with the guidelines of the Traffic Accident and Patient Injury Board, and depends on such factors as the size, shape, colour, location and visibility of the scar or other cosmetic harm. It also varies according to the age of the injured party.
Loss of earnings. Insurance compensation may be payable for a loss of earnings suffered by an injured employee or self-employed person. This compensation for lost earnings may be transitory or permanent. Transitory compensation for lost earnings may be payable for a period during which the injured party was unable to work normally. Permanent compensation for lost earnings may be payable if the pharmaceutical product damage has caused the injured party to suffer a permanent reduction in capacity to work. Compensation for lost earnings is payable from pharmaceutical insurance only insofar as the injured party does not receive statutory compensation. This means that any per diem allowances and pensions payable pursuant to such statutes as the Health Insurance Act (sairausvakuutuslaki, no. 1224 of 2004), the Traffic Insurance Act (liikennevakuutuslaki, no. 460 of 2016), the Workers’ Compensation Act (työtapaturma- ja ammattitautilaki, no. 459 of 2015) earnings-related pensions legislation, the National Pensions Act (kansaneläkelaki, no. 347 of 1956) and the Patient Injuries Act (Potilasvahinkolaki, no. 585 of 1986) will be deducted from the compensation payable under pharmaceutical insurance.

Deceased Vaccine recipients

Maintenance for survivors. The beneficiaries potentially eligible for maintenance are a surviving spouse and minor children, in certain cases children under 21 years of age and in education will also be eligible. This compensation is only payable insofar as other income and statutory benefits of the beneficiary, such as survivors’ pension, do not meet the minimum necessary maintenance levels.
Funeral costs. The reasonable funeral costs and associated expenses of the injured party may be reimbursed in the event of death. This insurance compensation may cover such items as the costs of a burial plot, coffin, gravestone, funeral service, flowers, obituary notice and mourning clothes. The costs of compiling the estate inventory are not covered. Funeral costs are reimbursed to the death estate or to the person who incurred the said costs out of pocket.

Payments consist of a lump sum payment.

Funeral expenses are available under this NFCS.

Compensation under this scheme calculated on an individual basis using tariffs/guidelines to assist with quantification.

Loss of earnings are paid under this scheme. They are quantified on an individual basis.

Compensation under this scheme is capped, with a top lifetime claim value of €4 million.

There is a minimum claim value under this NFCS of €85.

Time limits for claims

The scheme does not set a time limit between vaccination and the adverse event occurring.

A claim under the scheme must be brought within 1 year of becoming aware of the injury, with a ten year longstop.

Evaluating claims – standard of proof required

Claims are submitted to the Finnish Mutual Insurance Company for Pharmaceutical Injury Indemnities, who collect the required information from the healthcare organisations. A claim settler examines the claim to see if it meets the eligibility requirements set out in the Terms and Conditions. This involves clarifying if the symptoms suffered could be due to the vaccine. This usually requires obtaining the opinion a specialist doctor. The standard of proof required by the scheme is that on the balance of probabilities the vaccination caused the adverse event. If there are multiple possible causes of the injury the vaccine must be the most likely cause.

Appeals and the right to litigate

The right to litigate is not affected by use of the scheme - A claimant has a free choice to use the scheme or to litigate. However, if a claimant succeeds in their NFCS claim they sign over their rights to compensation from any other source (except state benefits) to the NFCS, as specified in the Terms and Conditions 9.2

Dissatisfied claimants have various options open to them. There is an internal appeals process where the NFCS itself reviews the decision and there is an external review process where another organisation reviews the decision. A claimant can contact the Finnish Mutual Insurance Company for Pharmaceutical Injury Indemnities and request a correction, any new information should be included in this request.

Claimants can also request a recommendation from the Finnish Financial Ombudsman Bureau (FINE). There are no formalities involved in submitting such a request. FINE processes settlement recommendation requests either in-house or by referring them to the Finnish Insurance Complaints Board. Requests concerning pharmaceutical insurance are generally referred to the Finnish Insurance Complaints Board. Either FINE or the Finnish Insurance Complaints Board will issue a substantiated written settlement recommendation for the case. This procedure is free of charge to applicants. A request to FINE must be submitted within three years after receiving notification of the decision of the insurance company.

There is also the option to issue legal proceedings by bringing an action against the Finnish Mutual Insurance Company for Pharmaceutical Injury Indemnities. This action must similarly be brought no later than three years after receiving notification of the decision of the insurance company.